VETERANS ADMINISTRATION 
Department of Medicine and Surgery 
Washington, D.C. 20420 
CEP i s 1978 
IN REPLY 
REFER TO: 15 
• 
Donald S. Fredrickson, M.D. 
Director 
National Institutes of Health 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
The Veterans Administration welcomes the opportunity to connent on the 
proposed revised guidelines for recombinant ENA research as published 
in the Federal Register, Vol. 43, No. 146, page 33042 to 33178, 
July 28, 1978. The VA very much prefers guidelines rather than 
regulations or legislation in this scientific area. 
In general, the Veterans Administration finds the new guidelines 
thoughtfully conceived, satisfactorily flexible, and conservative 
enough to afford protection where it is needed. We welcome also the 
recognition that the individual institution is responsible for the 
conduct of recombinant DNA experiments. 
It should prove helpful also that the opponents of ENA research must be 
prepared to show that the procedure they are protesting has a true 
potential for being unsafe. This shift in the burden of proof should 
minimize unwarranted interference with scientific progress. 
Our comments suggesting reconsideration center around the various 
committees and their relation to the Director of the National 
Institutes of Health. We feel that the Recombinant ENA Advisory 
Committee properly has been assigned an important role and that great 
dependence is placed on its scientific judgment. Under these 
circumstances, it would be appropriate for other federal agencies 
engaged in ENA research to propose members for this Committee. 
There is a question concerning the jurisdiction of various government 
agencies, including the Veterans Administration, over research funded 
and conducted by than including investigations by their own employees 
and in their own facilities. It is not clear what control the National 
Institutes of Health would have over such research. The Federal 
Interagency Committee on Recombinant ENA Research could provide 
coordination of policies in this area as suggested on page 33051 but it 
would have to have a much more active role than it has in the immediate 
past. 
It would be preferable, we feel, to have a small committee consider 
waivers of prohibitions and other exceptions to the guidelines instead 
of vesting this function in the Director of the National Institutes of 
[A— 162] 
'To care for him who shall have borne the battle, and for his • idow, and his orphan, ’-abraham Lincoln 
